Recovery Among Older Adults Following Mild TBI
ConditionMild Traumatic Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorUniversity of Maryland, Baltimore
About this trial
Among fall related injuries in older adults, head injuries are the most common, yet almost nothing is known about recovery from head injury, also known as traumatic brain injury or TBI, in this population. The RETRO-TBI study is a prospective cohort study of 250 adults aged 65 and older with mild TBI to evaluate recovery in cognitive, physical and psychological function and sleep quality at four timepoints (2 weeks and 3, 6, and 12 months) over the year following injury and identify factors associated with recovery trajectories. The potential impact of this work is that it will generate new knowledge that will guide targeted treatment efforts and inform future development of strategies to optimize recovery following this common fall-related injury among older adults.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 65 years or older
Treated for mild TBI (defined below) at the R Adams Cowley Shock Trauma Center (STC) or at one of six University of Maryland Affiliated Hospitals within 72 hours of injury
Traumatically induced physiological disruption of brain function, as manifested by at least one of the following 1) loss of consciousness ≤30 minutes, post-traumatic amnesia <24 hours, observed or self-reported transient confusion, disorientation, or impaired consciousness, or neurologic deficit as defined by a Glasgow Coma Scale (GCS) score of 13-14 on admission.
GCS of 15 with no other evidence of mild TBI was also accepted with positive computed tomography image.
Disqualifiers
Injury to any other body region resulting in an abbreviated injury scale (AIS) score >2
Anticipation that patient would not be ambulatory at 2-weeks post-injury
History of dementia as determined by patient/proxy report or medical history
Non-ambulatory pre-injury
Trial population
Study population consists of adults aged 65 or older who live within 55 miles of the University of Maryland Medical Center and who have been treated for a mild traumatic brain injury at a participating emergency department within 72 hours of injury.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Physical function
Short Physical Performance Battery total score. Range 0-12, Higher scores indicating better lower extremity function
Time frame
2 weeks, 3, 6, and 12 months2
Cognition
Repeatable Battery for the Assessment of Neuropsychological Status total scaled score. The scaled score is age adjusted with a mean of 100 and a standard deviation of 15. Scores below 100 indicate poorer cognitive function relative to same-age peers.
Time frame
2 weeks, 3, 6, and 12 months3
Sleep quality
Sleep duration in hours obtained from averaging values from participant's 1-week sleep diary. Healthy sleep duration for older adults ranges between 7-8 hours per night.
Time frame
2 weeks, 3, 6, and 12 months4
Psychological function
Geriatric depression scale, 15-item version. Range 0-15 with higher scores indicating more severe symptoms of depression.
Time frame
2 weeks, 3, 6, and 12 monthsSecondary outcomes
1
Physical Function
The Four-Step Square Test, measured as the number of seconds needed to complete the test. Values greater than 15 seconds are associated with increased fall risk.
Time frame
2 weeks, 3, 6, and 12 months2
Physical Function
Activities of Daily Living, range 0-6 with higher scores indicating increased independence in activities of daily living
Time frame
2 weeks, 3, 6, and 12 months3
Physical Function
Instrumental Activities of Daily Living, range 0-8 with higher scores indicating independence in instrumental activities of daily living
Time frame
2 weeks, 3, 6, and 12 months4
Physical Function
Glasgow Outcomes Scale Extended, range 1-8 with higher scores indicating better recovery following traumatic brain injury
Time frame
2 weeks, 3, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov